Role DescriptionIn your role as quality engineer, you will assure that all procedures are compliant and that regulation and legal documentation are completed. Your main focus is on the improvement and the maintenance of the Quality Management System. You will overview and control all procedures and required documentation for the compliancy of the QMS. In addition, you are the key contact person when there are any questions or particular issues about quality topics for both internal and external stakeholders. For example, when it concerns internal and external audits. Finally, you will be involved with risk assessment, validation management, and CAPA management.

ResponsibilitiesYour priority lies in overviewing and improving the Quality Management System. In collaboration with your team, you will bring new ideas to the quality system. Further responsibilities are: • You will be on track with the latest developments and changes of QA within the Medical Devices sector• Development of strategic plans and implementation tools for the improvement of the Quality Management System• Overview and collect required documentation and legislation in relation to the product specifications• Review and assessment of procedures involving risk and validation management at the manufacturing site• Development of strategic plans and implementation tools for the improvement of the Quality Management System

Requirements• Bachelor or Master in Life Sciences• Minimal 3-5 years of experience within QA in the Medical Devices• Excellent knowledge of quality standards such as ISO 13485, 21CFR820, GMP, ISO14971 • Knowledge of procedures such as validation and equipment• Extensive knowledge of EU and US Medical Devices regulations• Excellent leadership and organisational skills • Fluency in English and Dutch • Strong communicator and analytical skills

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.